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This study was conducted to determine the predictors of foot ulceration occurring in patients with rheumatoid arthritis (RA) without diabetes. A multi-centre case control study was undertaken; participants were recruited from eight sites (UK). Cases were adults diagnosed with RA (without diabetes) and the presence of a validated foot ulcer, defined as a full thickness skin defect occurring in isolation on / below the midline of the malleoli and requiring > 14 days to heal. Controls met the same criteria but were ulcer naive. Clinical examination included loss of sensation (10g monofilament); ankle-brachial pressure index (ABPI); forefoot deformity (Platto); plantar pressures (PressureStat); RA disease activity (36 swollen/tender joint counts) and the presence of vasculitis. History taking included past ulceration/foot surgery; current medication and smoking status. Participants completed the Health Assessment Questionnaire (HAQ) and Foot Impact Scale. A total of 83 cases with 112 current ulcers and 190 ulcer naïve controls participated. Cases were significantly older (mean age 71 years; 95 % confidence interval [CI], 69–73 vs. 62 years, 60–64) and had longer RA disease duration (mean 22 years; 19–25 vs. 15, 13–17). Univariate analysis showed that risk of ulceration increases with loss of sensation; abnormality of ABPI and foot deformity. Plantar pressures and joint counts were not significant predictors. HAQ score and history of foot surgery were strongly associated with ulceration (odds ratio [OR] = 1.704, 95 % CI 1.274–2.280 and OR = 2.256, 95 % CI 1.294–3.932). Three cases and two controls presented with suspected cutaneous vasculitis. In logistic regression modelling, ABPI (OR = 0.04; 95 % CI, 0.01–0.28) forefoot deformity (OR = 1.14; 95 % CI, 1.08–1.21) and loss of sensation (OR = 1.22; 95 % CI, 1.10–1.36) predicted risk of ulceration. In patients with RA, ABPI, forefoot deformity and loss of sensation predict risk of ulceration but, in contrast with diabetes, raised plantar pressures do not predict risk.

Clinical Efficacy of the First Metatarsophalangeal Joint Arthroplasty as a Curative Procedure for Hallux Interphalangeal Joint Wounds in Patients with Diabetes David G. Armstrong , DPM, MSC 1 , Lawrence A. Lavery , DPM, MPH 2 , Jefferey R. Vazquez , DPM 1 , Brian Short , DPM 1 , Heather R. Kimbriel , BA 1 , Brent P. Nixon , DPM, MBA 1 and Andrew J.M. Boulton , MD 3 4 1 Department of Surgery, Podiatry Section, Southern Arizona Veterans Affairs Medical Center, Tucson, Arizona 2 Department of Surgery, Texas A&M Health Science Center, Scott and White Hospital, Temple, Texas 3 Diabetes Research Institute, University of Miami, Miami, Florida 4 Department of Medicine, Manchester Royal Infirmary, Manchester, U.K Address correspondence and reprint requests to Dr. David Armstrong. Southern Arizona Veterans Affairs Medical Center, Department of Surgery, Podiatry Section, 3601 South Sixth Ave., Tucson, AZ. E-mail: armstrong{at}usa.net Abstract OBJECTIVE —To evaluate the safety and efficacy of first metatarsophalangeal joint arthroplasty compared with standard, nonsurgical management of wounds at the plantar hallux interphalangeal joint in patients with diabetes. RESEARCH DESIGN AND METHODS —We evaluated 41 patients with ulcers classified as University of Texas Grade 1A or 2A at the plantar aspect of the first metatarsophalangeal joint using a case-control model. Case subjects were patients treated with resectional arthroplasty and control subjects received standard nonsurgical care. Both groups received standard off-loading and wound care. Outcomes included time to healing, reulceration, infection, and amputation. RESULTS —The surgery group healed significantly faster than patients in the standard therapy group (standard 67.1 ± 17.1 versus sugery 24.2 ± 9.9 days, P = 0.0001), and they had fewer recurrent ulcers (standard 35.0 versus surgery 4.8%, P = 0.02, odds ratio 7.6, 95% CI 1.1–261.7) Both groups had similar rates of infection (standard 38.1 versus surgery 40.0%, P = 0.9) and amputation (standard 10.0 versus surgery 4.8%, P = 0.5). CONCLUSIONS —Results suggest that resectional arthroplasty is a safe and effective procedure to treat wounds of the plantar hallux compared with nonsurgical therapy. Footnotes A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. Accepted September 7, 2003. Received July 21, 2003. DIABETES CARE

Aims/hypothesis Outcome data on individuals with diabetic foot ulcers are scarce, especially in those with peripheral arterial disease (PAD). We therefore examined the clinical characteristics that best predict poor outcome in a large population of diabetic foot ulcer patients and examined whether such predictors differ between patients with and without PAD. Methods Analyses were conducted within the EURODIALE Study, a prospective cohort study of 1,088 diabetic foot ulcer patients across 14 centres in Europe. Multiple logistic regression modelling was used to identify independent predictors of outcome (i.e. non-healing of the foot ulcer). Results After 1 year of follow-up, 23% of the patients had not healed. Independent baseline predictors of non-healing in the whole study population were older age, male sex, heart failure, the inability to stand or walk without help, end-stage renal disease, larger ulcer size, peripheral neuropathy and PAD. When analyses were performed according to PAD status, infection emerged as a specific predictor of non-healing in PAD patients only. Conclusions/interpretation Predictors of healing differ between patients with and without PAD, suggesting that diabetic foot ulcers with or without concomitant PAD should be defined as two separate disease states. The observed negative impact of infection on healing that was confined to patients with PAD needs further investigation.

Low-intensity laser irradiation improves skin circulation in patients with diabetic microangiopathy. A Schindl , M Schindl , H Schön , R Knobler , L Havelec and L Schindl Division of Special and Environmental Dermatology, University of Vienna Medical School, Austria. andreas.schindl@akh-wien.ac.at Abstract OBJECTIVE: Diabetic foot problems due to angiopathy and neuropathy account for 50% of all nontraumatic amputations and constitute a significant economic burden to society. Low-intensity laser irradiation has been shown to induce wound healing in conditions of reduced microcirculation. We investigated the influence of low-intensity laser irradiation by means of infrared thermography on skin blood circulation in diabetic patients with diabetic microangiopathy. RESEARCH DESIGN AND METHODS: Thirty consecutive patients with diabetic ulcers or gangrenes and elevated levels of glycosylated hemoglobin were randomized by blocks of two to receive either a single low-intensity laser irradiation with an energy density of 30 J/cm2 or a sham irradiation over both forefoot regions in a double-blind placebo-controlled clinical study. Skin blood circulation as indicated by temperature recordings over the forefoot region was detected by infrared thermography. RESULTS: After a single transcutaneous low-intensity laser irradiation, a statistically significant rise in skin temperature was noted (P < 0.001 by ANOVA for repeated measurements), whereas in the sham-irradiated control group, a slight but significant drop in temperature (P < 0.001) was found. Subsequently performed contrasts for comparison of measurements before and after irradiation revealed significant temperature increases at 20 min of irradiation time (P < 0.001), at the end of the irradiation (P < 0.001), and 15 min after stopping the irradiation (P < 0.001). In the sham-irradiated feet, the drop in local skin temperature was not significant at 20 min (P = 0.1), but reached significance at the end of the sham-irradiation procedure (P < 0.001) and 15 min after the end of sham irradiation (P < 0.001). CONCLUSIONS: The data from this first randomized double-blind placebo-controlled clinical trial demonstrate an increase in skin microcirculation due to athermic laser irradiation in patients with diabetic microangiopathy.

Aims/hypothesisThe aim of this study was to determine whether social deprivation in the presence of diabetes is an independent predictor of developing a foot ulcer and separately of mortality.MethodsThis was a primary-care-based retrospective analysis of 13,955 adults with type 1 (n = 1370) or type 2 (n = 12,585) diabetes after a median follow-up of 10.5 years. Demographic characteristics, indices of social deprivation and clinical variables were assessed at baseline. The primary outcomes were new foot ulceration (in those without a previous history of foot ulcers) and all-cause mortality. Cox proportional hazard models were used to describe the associations among foot ulceration, social deprivation and mortality.ResultsThe mean age of the population was 69.4 (range: 16–89) years. The incidence of foot ulceration was greater in individuals with type 2 (8.6%) compared with type 1 diabetes (4.8%). Occurrence was similar by sex, but increased with age and deprivation index. Individuals in the highest quintile of deprivation were 77% more likely to develop a foot ulcer compared with those in the lowest quintile (OR 1.77 [95% CI 1.45, 2.14], p < 0.0001). Overall, 2946 (21.1%) deaths were recorded. Compared with individuals without a foot ulcer, the development of a foot ulcer was associated with a higher age- and sex-adjusted mortality rate (25.9% vs 14.0%), and a 72% (HR 1.72 [95% CI 1.56, 1.90], p < 0.001) increased risk of mortality in those with type 2 diabetes. Risk of death increased by 14% per quintile of deprivation in a univariable analysis (HR 1.14 [95% CI 1.10, 1.17]). In multivariable Cox regression analyses, there was a 48% increased risk of mortality in individuals with a foot ulcer (HR 1.48 [95% CI 1.33, 1.66]) independent of the Townsend index score (HR 1.13 [95% CI 1.10, 1.17], per quintile), baseline age, sex, diabetes type, smoking status, hypertension, statin use, β-blocker use, metformin use, HbA1c levels and insulin use.Conclusions/interpretationThis study confirms the high mortality rate in individuals with diabetes-related foot ulcers. In addition, socioeconomic disadvantage was found to be an independent effect modifier, contributing to an increased burden of mortality in people with diabetes who develop foot ulceration. In light of this, and as diabetes service configurations are orientated for the next 5–10 years, modelling of foot ulceration risk needs to take socioeconomic disadvantage into account.

We first compared long-term clinical outcomes in treating critical limb ischemia (CLI) and foot ulcer in patients with diabetes between autologous bone marrow mesenchymal stem cell (BMMSC) and bone-marrow-derived mononuclear cell (BMMNC) transplants. Forty-one patients were enrolled and followed up for 3 years. They received an 18-day standard treatment before stem cell transplantation. Patients with bilateral CLI and foot ulcer were injected intramuscularly or basally with BMMSC, BMMNC, or normal saline (NS). Cox model analysis showed significant differences in the hazard ratio (HR) for amputation with treatment by BMMSC (HR 0.21 [95% CI (0.05, 0.95)], P = 0.043), infection of foot (HR 5.30 [95% CI (1.89, 14.92)], P = 0.002), and age ≥64 (HR 3.01 [95% CI (1.11, 8.15)], P = 0.030), but no significant differences by BMMNC at 9 months after transplantation. Regarding ulcer healing and recurrence rate, the BMMSC group demonstrated a significant difference from the NS group during the 3–6 months after transplantation or healing, but the BMMNC group did not. This trial suggests that, compared with BMMNC treatment, BMMSC treatment leads to a longer time of limb salvage and blood flow improvement, and, when compared with conventional therapy, it can promote limb blood flow and ulcerative healing, and reduce ulcer recurrence and amputation within 9 months.

We estimated the occurrence of diabetic neuropathy using six different diagnostic modalities in individuals with newly diagnosed diabetic foot ulcers (DFUs) and assessed the association with DFU healing time. All individuals with DFU had distal symmetrical polyneuropathy. Presence of neuropathy did not associate with ulcer healing time (p ≥ 0.12). •All individuals with a diabetic foot ulcer had distal symmetrical polyneuropathy evaluated by at least one of the modalities•None of the examined tests for diabetic neuropathy were associated with healing time of the diabetic foot ulcer•The DPNCheckTM device seems to have limited usability in individuals with a diabetic foot ulcer

OBJECTIVE: The purpose of this study was to compare mortality risks of patients with Charcot arthropathy with those of patients with diabetic foot ulcer and those of patients with diabetes alone (no ulcer or Charcot arthropathy). RESEARCH DESIGN AND METHODS: A retrospective cohort of 1,050 patients with incident Charcot arthropathy in 2003 in a large health care system was compared with patients with foot ulcer and those with diabetes alone. Mortality was determined during a 5-year follow-up period. Patients with Charcot arthropathy were matched to individuals in the other two groups using propensity score matching based on patient age, sex, race, marital status, diabetes duration, and diabetes control. RESULTS: During follow-up, 28.0% of the sample died; 18.8% with diabetes alone and 37.0% with foot ulcer died compared with 28.3% with Charcot arthropathy. Multivariable Cox regression shows that, compared with Charcot arthropathy, foot ulcer was associated with 35% higher mortality risk (hazard ratio 1.35 [95% CI 1.18-1.54]) and diabetes alone with 23% lower risk (0.77 [0.66-0.90]). Of the patients with Charcot arthropathy, 63% experienced foot ulceration before or after the onset of the Charcot arthropathy. Stratified analyses suggest that Charcot arthropathy is associated with a significantly increased mortality risk independent of foot ulcer and other comorbidities. CONCLUSIONS: Charcot arthropathy was significantly associated with higher mortality risk than diabetes alone and with lower risk than foot ulcer. Patients with foot ulcers tended to have a higher prevalence of peripheral vascular disease and macrovascular diseases than patients with Charcot arthropathy. This finding may explain the difference in mortality risks between the two groups.

OBJECTIVE:--The objective of this study was to evaluate the association between foot ulcers (DFU) and lower-extremity amputation (LEA) and chronic kidney disease (CKD) in patients with diabetes. RESARCH DESIGN AND METHODS--This was a retrospective cohort study of individuals enrolled between 2002 and 2006 who were aged >=35 years, had a history of diabetes, and were cared for in general practice. The physicians participated in The Health Information Network of the U.K. RESULTS:--The presence of DFU or LEA and estimated glomerular filtration rate (eGFR) were evaluated in 90,617 individuals with a median time of observation of 2.4 years. Of these individuals 378 had an LEA and 2,619 had a DFU. CKD (eGFR <60 ml/min per 1.73 m²) was noted in 23,350 (26%) individuals in our cohort. For the development of DFU compared with our reference group (group 1 [eGFR >=60 ml/min per 1.73 m²]), the hazard ratio (HR) for group 2 (eGFR >=30 and <60 ml/min per 1.73 m²) was 1.85 (95% CI 1.71-2.01) and for group 3 (eGFR <30 ml/min per 1.73 m²) was 3.92 (3.23-4.75) (all P < 0.001). For LEA, the HR for group 2 was 2.08 (1.68-2.58) and for group 3 was 7.71 (5.29-11.26) (all P < 0.001). CONCLUSIONS:--In this observational study, there is a strong association between stage of CKD and DFU or LEA that is probably not just related to the presence of peripheral arterial disease. Individuals with even moderate CKD (eGFR <60 ml/min per 1.73 m²) have an increased risk for DFU and LEA.

Background There are no current Australian guidelines on the prevention of diabetes-related foot ulceration (DFU). A national expert panel aimed to systematically identify and adapt suitable international guidelines to the Australian context to create new Australian evidence-based guidelines on prevention of first-ever and/or recurrent DFU. These guidelines will include for the first-time considerations for rural and remote, and Aboriginal and Torres Strait Islander peoples. Methods The National Health and Medical Research Council procedures were followed to adapt suitable international guidelines on DFU prevention to the Australian health context. This included a search of public databases after which the International Working Group on the Diabetic Foot (IWGDF) prevention guideline was deemed the most appropriate for adaptation. The 16 IWGDF prevention recommendations were assessed using the ADAPTE and GRADE systems to decide if they should be adopted, adapted or excluded for the new Australian guideline. The quality of evidence and strength of recommendation ratings were re-evaluated with reference to the Australian context. This guideline underwent public consultation, further revision, and approval by national peak bodies. Results Of the 16 original IWGDF prevention recommendations, nine were adopted, six were adapted and one was excluded. It is recommended that all people at increased risk of DFU are assessed at intervals corresponding to the IWGDF risk ratings. For those at increased risk, structured education about appropriate foot protection, inspection, footwear, weight-bearing activities, and foot self-care is recommended. Prescription of orthotic interventions and/or medical grade footwear, providing integrated foot care, and self-monitoring of foot skin temperatures (contingent on validated, user-friendly and affordable systems becoming available in Australia) may also assist in preventing DFU. If the above recommended non-surgical treatment fails, the use of various surgical interventions for the prevention of DFU can be considered. Conclusions This new Australian evidence-based guideline on prevention of DFU, endorsed by 10 national peak bodies, provides specific recommendations for relevant health professionals and consumers in the Australian context to prevent DFU. Following these recommendations should achieve better DFU prevention outcomes in Australia.